What do scores mean in the competency matrix?
You can personalize that in Scilife, each company can create its own scoring system. You can either have numeric scores (from 1 to 5 or whatever you consider appropriate) or other scoring systems (beginner, intermediate, expert, etc.).
Is the personnel training record only visible to the managers and his/herself or company-wide?
You can configure access controls in Scilife to meet your company requirements.
This looks like an interesting tool, would it be possible to access the pre-production or playground environment for us to assess if this is something we would want?
Sure, we have a standard process for this. It is a guided Sandbox / POC and it includes a Kick-Off session in which we give you 1-hour training and help you set up and configure the necessary elements in Scilife so that your trial is focused on testing the system and that you get the most out of it. We will also create some content based on your templates and we will include 2 Q&A sessions, one at the end of the first week, and another at the end of the second. The POC lasts for 2 weeks and it has a 500€ cost, which is discounted later on if you become a customer.
Sometimes during an audit, the auditor may disagree with regulatory guidance provided by others. In such cases, complexity and critical observations may arise. What recommendations would you make to minimize these complexities?
In my experience, when there is a disagreement between the auditor and the auditee, presenting concrete evidence and using relevant guidelines and regulations to discuss specific topics is essential. It is important to have the necessary evidence readily available when discussing specifications, analytical methods, or any other aspect of the audit. Additionally, demonstrating to the auditor that everything is under control and well-organized is crucial to minimize complexity.
Using Scilife can greatly improve the quality management system and make the audit process more efficient. With Scilife, everything is connected, and at the click of a button, you can show the auditor the entire system, which saves time for both parties involved. By employing these strategies, the complexity of the audit can be minimized, and the audit process can be more productive and beneficial for everyone involved.
Can the admin role be able to configure the different fields in the module and assign the correct terms that the company is using, meaning the admin has the ability to reconfigure fields and selectable fields in the module?
Is there also an analytics module where we can configure it based on how we do analysis based on our own KPIs?
Custom fields in Events can be created and edited by Admin and Managers, but the standard fields and nomenclature of the system cannot be modified in the system. This is something that can be done with the Quality Process Designer, with which you can customize the whole workflow with all its forms, fields, roles, and statuses.
Is the system cloud-based, and if so, where is the data located, is it secure?
Yes, our system is cloud-based, and we use Amazon Web Services (AWS) as our infrastructure provider. AWS has the necessary certifications to work with highly regulated sectors, including Pharma and Life Sciences, as well as other industries like Banking. We offer our customers the option to choose between two data centers - one located in Europe and the other in the US - depending on their regulatory requirements.
For example, most European companies need to comply with the European regulations, so their data is hosted in the European data center. In summary, our cloud-based system is hosted on AWS, which has the necessary certifications for highly regulated sectors, and we offer our customers the choice of data center location depending on their regulatory requirements. We have implemented robust security measures to protect the privacy and integrity of our customers' data.
Can Scilife generate reports or analytics, such as KPIs, to help us track our compliance progress? For example, can we report on CAPAs that have been completed or are overdue?
Yes, Scilife offers two options to generate reports and analytics for compliance tracking. Firstly, you can use the CAPA module to filter CAPAs based on various criteria, such as those that are overdue, and then export the filtered list. Alternatively, you can use our KPI model, which provides reports for various models.
Using the KPI model, you can view information such as all CAPAs that are overdue, all CAPAs that were closed on time, all CAPAs that were closed late, and the time spent at each stage of the CAPA process. You can view this information for the present as well as historical data, which enables you to assess your current compliance status and track progress over time.
This feature is particularly useful if you have a continuous improvement goal, as you can set targets and track how your KPIs are evolving over time. With Scilife, you can generate detailed reports and analytics to help you track compliance progress, identify areas of improvement, and optimize your compliance efforts.
Is there any popup email provision before the time line of action closure and if yes then how many days before?
Yes, Scilife provides email notifications before an item is due, and this feature is fully configurable. You can choose how many days in advance you want to receive these notifications, based on the specific requirements of your organization. For example, if your periodic review is due every 12 months, you can set the system to notify you about the upcoming review, say, 60 days in advance.
These notifications will appear on your dashboard, and you will also receive an email notification to ensure you never miss a deadline. This feature ensures that you can stay on top of all your compliance tasks and avoid any potential issues related to missed deadlines. With Scilife, you can easily configure email notifications to suit your organization's needs, and stay informed about upcoming deadlines.
Does the supplier management module allow for the planning of supplier audits, requalification of suppliers, management of supplier corrective action requests (SCARs), and supplier categorization? Can the module be customized by the admin to align with the company's specific terminologies
Supplier management is quite a new module and it is being actively developed in terms of new functionalities. It already includes the possibility of creating linked audits to the supplier and planning this audit. You can requalify suppliers as well. At the moment for SCARs, and more customization, the Quality Process Designer would be required, as this isn’t available within Supplier Management.
